SPL v2
SPL
SPL Set ID 6175419e-9faa-4b23-bc29-24f24e958880
Route
ORAL
Published
Effective Date 2013-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Starch, Corn Povidone K30 Methylparaben Titanium Dioxide Magnesium Stearate Talc Sodium Starch Glycolate Type A Potato Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 25mg Shape: round Color: white Size: 4 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-01

Description

DIPHENHYDRAMINE HYDROCHLORIDE

Purpose

Antihistamine


Medication Information

Warnings and Precautions

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Purpose

Antihistamine

Description

DIPHENHYDRAMINE HYDROCHLORIDE

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose

Section 51727-6

MAGNESIUM STEARATE

Section 51945-4
Directions

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 tablet) every 4 to 6 hours; not more than 12 tablets in 24 hours.



Children 6 years to 12 years of age
: take 25 mg (1 tablet) every 4 to 6 hours; not more than 6 tablets in 24 hours.



Children under 6 years of age
: ask a doctor



Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Inactive Ingredient

CELLULOSE, MICROCRYSTALLINE

Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Structured Label Content

Uses (uses)

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose

Warnings and Precautions (34071-1)

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Section 51727-6 (51727-6)

MAGNESIUM STEARATE

Section 51945-4 (51945-4)
Purpose (purpose)

Antihistamine

Directions (directions)

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 tablet) every 4 to 6 hours; not more than 12 tablets in 24 hours.



Children 6 years to 12 years of age
: take 25 mg (1 tablet) every 4 to 6 hours; not more than 6 tablets in 24 hours.



Children under 6 years of age
: ask a doctor



Active Ingredient (active ingredient)
DIPHENHYDRAMINE HYDROCHLORIDE
Inactive Ingredient (inactive ingredient)

CELLULOSE, MICROCRYSTALLINE

Keep Out of Reach of Children (keep out of reach of children)
In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Advanced Ingredient Data


Raw Label Data

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